FDA Enforcement
Class II
Terminated
Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
Recall: Z-0997-2020
·
Reported February 12, 2020
Enforcement
- Recall Number
- Z-0997-2020
- Event ID
- 84518
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Roche Diabetes Care, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 12, 2020
- Initiation Date
- December 11, 2019
- Classification Date
- February 5, 2020
- Termination Date
- July 8, 2022
- Address
- 9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States
Description
Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
Reason
Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions
Code Info
Lot Number: 497864 NDC: 65702-0438-10 UPC: 3-65702-43810-1
Distribution
Nationwide: Foreign: Austalia, India
Quantity
82,332 vials